(Reuters) – U.S. Food and Drug Administration staffers reviewing Amarin Corp Plc’s fish oil-derived drug said on Tuesday the agency’s tests were inconclusive on whether the use of mineral oil as placebo in the company’s trial could have impacted results.
Shares of the company jumped 18.6% in premarket trading.
Vascepa, Amarin’s only drug, originally won U.S. approval in 2012 to lower high levels of triglycerides — a type of blood fat that can increase the risk of heart disease.
Amarin is now seeking to expand approval of the omega-3 fatty acid pill to make it a treatment for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.
An independent panel of experts is set to discuss the safety and effectiveness of the drug on Thursday.
Reporting by Saumya Sibi Joseph and Trisha Roy in Bengaluru; Editing by Maju Samuel